Appeals : Arbitrator
Decisions : #54 - August 15, 2002
D E C I S I O N
Claim No. 1300323
I. Issue
1. The question before me in this arbitration is whether
the Administrator was correct in denying the Claimant's Claim
for compensation on the basis that she did not receive transfused
Blood within the Class Period from a donor determined to be
HCV antibody positive.
II. Background
2. The Claimant submitted an application for compensation
as a Primarily-Infected Person under the Transfused HCV Plan
(the "Plan") established by the 1986-1990 Hepatitis
C Settlement Agreement (the "Settlement Agreement")
approved by Order dated October 28, 1999 of the Supreme Court
of British Columbia. The terms of the settlement are pan-Canadian
and set out in detail the claims process for determining eligibility
and proof of eligibility.
3. By letter dated May 10, 2001, the Administrator denied
the Claim on the basis that there was no evidence the Claimant
was infected for the first time with HCV via Blood transfusion
received in Canada during the Class Period.
4. The Claimant requested review of the Administrator's denial
of the Claim by way of arbitration.
5. The Claimant through her authorized representative requested
an in-person hearing. The in-person hearing was conducted
on March 1 and June 14, 2002 in Vancouver.
6. As the arbitrator and trier of fact, I am required to give
reasons for my decision. An arbitrator's reasons for decision,
like a judge's reasons for judgment, are not intended to be
a recitation of all the evidence and submissions tendered
during the conduct of the arbitration. I have had the benefit
of considerable written and oral evidence and I have had the
benefit of able submissions, in writing and orally, from the
Claimant's representative and Fund Counsel. I have carefully
considered all of the evidence and submissions in arriving
at my decision. That I choose to refer or advert to only some
of the evidence and the submissions does not mean that I have
not considered everything put before me.
III. Facts
7. The Claimant is infected with Hepatitis C. She suffered
liver failure and had a liver transplant in October 1994.
She testified at the hearing. I found her to be a woman of
great honesty and dignity. She has been extremely courageous
in dealing with the ravages of a terrible disease.
8. The Claimant received two transfusions in 1988 during the
Class Period. Evidence was submitted that the Claimant also
received transfusions after the Class Period. The Claimant
testified she began feeling ill after 1988.
9. In 1988 the Claimant had back surgery involving an acute
lumbar disc which resulted in a discectomy and laminectomy.
She was transfused with two units of blood at the time of
the back surgery on or about February 29, 1988. There were
two donors identified with the Claimant's 1988 transfusions.
10. According to the medical evidence, the Claimant was negative
for risk factors associated with HCV. She and her representative
maintained that the 1988 blood transfusions were the only
possible source of her infection.
11. The Claimant initiated a Traceback procedure in 1998 on
her own. During the administration of the Claim, the Administrator
also initiated a Traceback which was joined with the Claimant's
Traceback.
12. Canadian Blood Services ("CBS") concluded the
Traceback under what is referred to as the Litigation Notification
Program. The Traceback results were negative for the two donors
associated with the transfusions in February of 1988. One
donor had been tested for the HCV antibody in April of 1993
as part of the routine screening process when an individual
donates blood in Canada. The second donor was tested on January
4, 2001 for the HCV antibody as part of the Traceback Protocol.
CBS reported the results of the Traceback to the Administrator
in January 2001.
13. Both donors had been tested for the HCV antibody by what
is called an optical density test. The Hepatitis C antibody
test uses the enzyme imunoassay method, usually abbreviated
as EIA or ELISA. Blood may also be tested for the hepatitis
C virus itself by a test known as a PCR test. PCR stands for
polymerase chain reaction. A PCR test detects the presence
of the actual hepatitis C virus in the person's blood. The
nucleic acid (RNA) of the virus is detected. It is referred
to as the NAT, or nucleic acid test, as well. Since 1999 blood
donors have been screened using both the EIA test and the
PCR test.
14. The Traceback investigation dealt with the two units of
blood given the claimant in 1988, which were referred to as
unit numbers 285668 and 229018. I will refer to the first
donor as the one associated with unit 285668; I will refer
to the second donor as associated with unit 229018. Unit 285668
was described as red cells. Unit 229018 was described as stored
plasma. Unlike the case with the first donor where there was
an HCV test on file, there was no HCV test on file in connection
with the second donor. CBS, following the Traceback Protocol,
contacted the donor and the donor gave a sample of blood in
January 2001. At the time of the March 1, 2002 hearing, Ms.
Lindsay Patterson, employed as the Coordinator, National Lookback/Traceback
Program at the Head Office of CBS in Ottawa, testified that
she did not know if the sample of blood given by the second
donor in January 2001 was still in existence. As a result,
I permitted the parties an opportunity to apply to re-open
the hearing for the purpose of submitting further evidence
concerning the Traceback relating to the second donor. An
application was made and further evidence was taken on June
14, 2002.
15. On June 14, 2002 Ms. Patterson testified again as did
Ms. Petra Welsh, laboratory manager of the B.C. and Yukon
Centre for CBS. Ms. Welsh works at the Vancouver Blood Centre
on Oak Street in Vancouver. She testified that the laboratory
tested a sample of the second donor's blood for the HCV antibody.
The results of the test were submitted to CBS in Ottawa and
were recorded on the Traceback file. By standard operating
procedures, the sample of blood was tested only by the EIA
antibody test and not the PCR test. The sample was destroyed
within days of its testing following standard operating procedure.
The samples are retained only if they are reactive.
IV. The Plan and the Traceback Protocol
16. The Plan requires the Administrator to determine whether
the source of a claimant's infection with HCV was Blood transfused
during the Class Period. As contemplated by Article 3.04(1)
of the Plan, the Administrator pursued the Traceback Procedure
to determine whether that blood was the source of the HCV.
17. In article 1.01 of the Plan the following definitions
appear:
"HCV Antibody Test" means a blood test performed
in Canada using a commercially available assay acceptable
to the Administrator demonstrating that the HCV antibody is
present in the blood of a person.
"Traceback Procedure" means a targeted search
for and investigation of the donor and/or the units of Blood
received by a HCV Infected Person.
18. Article 3.04(1) provides:
if the results of a Traceback Procedure demonstrate
that none of the donors or units of Blood received
by a Primarily-Infected Person
during the Class Period
is or was HCV antibody positive, subject to the provisions
of section 3.04(2), the Administrator must reject the Claim
of such HCV person
. (emphasis added)
19. To summarize, Article 3.04(2) provides that notwithstanding
the results of the Traceback Procedure, a claimant may prove
by evidence he or she was infected for the first time with
HCV by a Blood transfusion received in Canada during the Class
Period.
20. As part of the Settlement Agreement, the courts have approved
a Traceback Protocol. An order of the Supreme Court of British
Columbia dated October 28, 1999, sets out the court approved
investigation procedure. An order of the same court dated
August 14, 2000, established the Protocol for Traceback Procedure.
By further order dated February 6, 2001, Smith, J. (as he
then was) approved an amended Protocol Criteria for Traceback
Procedure as set out in the form appended as Schedule 1 to
that order. Schedule 1 defines Traceback Procedure as a targeted
search which can include a Records Search, a Class Period
Search and/or a Pre-Class Period Search. A Records Search
is defined to mean "that stage of Traceback Procedure
where a search is conducted to match the units of Blood received
by an HCV Infected Person at any time against the records
of Canadian Blood Services ("CBS") and Hema-Quebec
to determine if the HCV antibody status of the donor
of some or all of the units received is known." Class
Period Search means "that stage of Traceback Procedure
where attempts are made to locate the donors of the units
of Blood received by an HCV Infected Person during the Class
Period and, where necessary, to have the donor tested to
determine his or her HCV antibody status." (emphasis
added)
21. In this case there was a Records Search for the first
donor and a Class Period Search for the second donor.
22. There is nothing in the court-approved Traceback Protocol,
directly or indirectly, calling for anything other than the
determination of the HCV antibody status of a donor.
23. I have read the court-approved Traceback Protocol with
care and I have concluded the Administrator in the case appropriately
followed the requisite procedures. A Records Search for the
first donor turned up a negative antibody test in 1993. A
Class Period Search for the second donor resulted in a negative
antibody test in 2001. Accordingly, by the terms of the Protocol,
the Administrator was bound to reject the Claim.
24. Paragraph 17 of the Protocol reads as follows:
SECTION 3.04(1) - REJECTION OF CLAIM
17. The Administrator shall, after determining in accordance
with the provisions of Section 3.04(1) of the Plan and subparagraph
7(a), 7(d)(i), 8(a), 8(b), 9(a), 9(d)(i), 9(f)(i), 10(a) or
10(d)(i) above that a Claim must be rejected based upon the
Traceback Procedure result, advise the claimant that, unless
the claimant provides further evidence of first infection
("Further Evidence of First Infection") which establishes
to the satisfaction of the Administrator that the person claimed
to be the Primarily-Infected Person was infected for the first
time with HCV by a Blood transfusion received in Canada during
the Class Period notwithstanding the Traceback Procedure result
in accordance with section 3.04(2) of the Plan, his or her
claim shall be rejected (a "Section 3.04 Letter").
25. The Administrator advised the Claimant by letter dated
March 19, 2001 that her Claim for compensation under the Settlement
Agreement would be rejected unless she could provide further
evidence that she was infected for the first time with HCV
by a Blood transfusion received in Canada during the Class
Period. The Claimant was advised that all donor searches were
complete and the Traceback results showed that the donors
or units of blood received in the Class Period were determined
to be negative for the HCV virus. Subsequently, the Administrator
was not satisfied that there was Further Evidence of First
Infection and accordingly the Claim was denied by letter dated
May 10, 2001.
26. The Claimant then initiated a request for review of the
Administrator's decision by way of arbitration.
V. The Evidence
For the Claimant
27. The Claimant testified as previously indicated. Her evidence
spoke volumes of the courage of some people to lead productive
lives in the face of great adversity. She is an admirable
woman. Unfortunately, on the issue before me, her evidence
was of little help.
28. Dr. Fraser Norrie submitted a report dated November 6,
2001 and testified on behalf of the Claimant. Dr. Norrie is
a dedicated general practitioner who treats a significant
number of patients with HIV/Aids and Hepatitis C. He conceded
that he was not as expert on matters relating to HCV as was
Dr. Steven Kleinman, who produced a report dated January 14,
2002 and testified on behalf of the Administrator as a pathologist
with an expertise in transfusion medicine, blood banking,
transfusion transmitted infections and diseases including
HCV. I accepted Dr. Norrie as a duly qualified medical expert
with a special interest in HIV/Aids and HCV.
29. Dr. Norrie testified that there may be a small cohort
of people who are infected with the virus but who do not develop
antibodies. He referred to patients in his practice who have
Hepatitis C and HIV but test negative for the Hepatitis C
antibody. He also referred to a letter dated May 3, 2001 authored
by two doctors at the British Columbia Centre for Excellence
in HIV/Aids at St. Paul's Hospital in which the doctors identified
two patients infected with HIV and Hepatitis C who repeatedly
tested negative for the Hepatitis C antibody but tested positive
on a PCR test for Hepatitis C. It was Dr. Norrie's opinion
that in the case of Tracebacks, the PCR test should be used
as well as the antibody test.
30. Dr. Norrie also discussed a cohort of people who may be
in the very early stages of the virus but have not developed
the antibody. I understand that CBS has screened donors since
1999 using both tests to capture results that may otherwise
be missed during that brief window.
31. Dr. Norrie also testified about the time frame between
HCV infection and liver failure. He testified that the typical
time frame is more in the range of twenty years but it is
not impossible for the disease to progress within six years,
as would have to be case here if the Claimant was first infected
with HCV in 1988.
32. Dr. Norrie also accepted in cross-examination that in
approximately 10% of the Hepatitis C cases the source of the
infection cannot be found.
33. Although I regarded Dr. Norrie as a conscientious and
dedicated physician, I did not find his evidence about PCR
testing particularly helpful since the Plan and the Traceback
Protocol require only antibody testing for a Traceback Procedure.
Additionally, the evidence from Dr. Kleinman offered a rational
basis for the use of only the antibody test for Traceback
investigations.
For the Administrator
34. As indicated, Dr. Steven Kleinman testified for the Administrator.
His professional work falls more in the fields of epidemiology
and public health rather than the care of individual patients.
He is currently a clinical professor of pathology at the Faculty
of Medicine, University of British Columbia and an adjunct
scientist to CBS. He has been a consultant to blood collection
agencies, hospitals, government and industry. I accepted Dr.
Kleinman as an expert on blood related diseases, blood screening,
blood collection and Tracebacks.
35. Dr. Kleinman testified about the typical length of time
for one to contract advanced liver disease after HCV infection.
He said it would be highly unusual for someone to have advanced
liver disease in six years but he would not say it could not
happen. He testified that statistically it is more likely
that a person would have advanced liver disease after twenty
years of infection rather than six years. He referred to scientific
literature to the effect that only 5% of the people who contract
advanced liver disease from HCV do so as early as 10 years
from the date of infection. This evidence of Dr. Kleinman
raises the significant possibility that the Claimant was infected
with the Hepatitis C virus prior to 1986, more likely in the
1970's. Dr. Kleinman also noted that although no other Hepatitis
C risk factors had been identified in this case, the US Centre
for Disease Control and Prevention states that no risk factor
is found in 10% of Hepatitis C cases.
36. Dr. Kleinman further testified that he is medically certain
that the donors in this case could not have been in the early
window of HCV infection without developing the antibody because
they had subsequent negative antibody tests. Dr. Kleinman
also testified that Hepatitis C Traceback investigations are
conducted to establish whether a blood donor may have been
infected with Hepatitis C virus at some time in the past such
that the donor may have transmitted the infection to a recipient
via a blood transfusion. Often, as in this case, testing of
a follow-up sample from a former blood donor will occur years
after the transfusion incident under investigation. The first
donor was tested five years after the transfusion under investigation.
The second donor was tested thirteen years later. According
to Dr. Kleinman, Hepatitis C antibody testing detects a response
of the infected person's immune system to exposure to the
Hepatitis C virus. This response generally occurs within the
first several months after exposure to the virus. Once such
a response occurs, it is long lasting and will last for decades
and probably for life in the vast majority of people.
37. Dr. Kleinman also testified that the Hepatitis C antibody
will persist both in persons who remain infected with Hepatitis
C as well as in persons whose immune system has been successful
in eradicating the Hepatitis C viral infection. Dr. Kleinman
also gave evidence that Hepatitis C antibody testing has been
proven by several long-term studies to be more effective than
PCR testing in detecting evidence of previous Hepatitis C
infection. Those studies show that 20 to 45% of persons known
to have been previously infected with HCV will test positive
for the antibody but negative for the virus by PCR testing
at approximately 17 to 23 years after initial infection.
38. Dr. Kleinman further testified that several versions of
the Hepatitis C antibody test have been licensed since 1990.
Each version has been licensed only after it has been validated
to perform reliably.
39. Dr. Kleinman also reviewed the antibody test results in
this case and he confirmed the results were clearly negative
and interpreted correctly.
40. Dr. Kleinman also testified that the rate of non-immunocompromised
donors who are HCV positive and antibody negative is one in
7.7 million. Although there was no screening for HCV in 1988,
there was screening for HIV. The two donors in question would
not have been infected with HIV.
41. In his report dated January 14, 2002, Dr. Kleinman came
to the following conclusions:
1. The possibility that one of the two hepatitis C antibody
negative blood donors transmitted hepatitis C to the appellant
at the time of their previous blood donations is extremely
remote. The literature data indicate that the frequency at
which a blood donor would be infectious (i.e. hepatitis C
PCR positive) and hepatitis C antibody negative is approximately
one in 7.7. million.
2. If the infection were to have occurred from these transfusions
given to the appellant in early 1988, the time course from
acquisition of hepatitis C infection to liver transplantation
would be less than seven years. This is a highly unusual time
course. The occurrence of liver failure in 1994 would be more
consistent with a date of infection that preceded 1986.
3. Absence of an identifiable source of hepatitis C infection
does not by default indicate that hepatitis C was acquired
from blood transfusion.
42. Other witnesses for the Administrator included (i) Carol
Miller, the appeal coordinator for the Administrator and a
registered nurse for more than 20 years; and as mentioned,
(ii) Lindsay Patterson, of CBS and (iii) Ms. Petra Welsh,
laboratory manager of the Vancouver Blood Centre. The evidence
of these three witnesses, taken together, satisfies me that
the Administrator and CBS followed the requisite procedures
and protocols in the investigation of the Claimant's Traceback
into whether or not the donors identified with the transfusion
in the Class Period were HCV antibody positive.
VI. Jurisdiction/Authority
43. The role of the Administrator under the Settlement Agreement
is to administer the Plan in accordance with its terms. The
Administrator has no discretion to allow compensation where
the required proof of entitlement does not exist. The Administrator
has no authority to alter or ignore the terms of the Plan.
As an arbitrator, my jurisdiction is limited as well. I too
am bound by the terms of the Settlement Agreement, the Plan
and court approved Protocols. I certainly cannot make a decision
contrary to them or amend them, even if I thought they were
deficient.
44. In a decision by Referee John Sanderson, Q.C., affirmed
by Mr. Justice Pitfield of the Supreme Court of British Columbia
in the matter of the HCV 1986-1990 Transfused Settlement Agreement
Re: Claim No. 1300430, 2002 BCSC 908, the Referee stated as
follows:
The words of Article 3.04(1) of the Plan are clear and
unambiguous that the Administrator '
must reject the
Claim
' in circumstances such as these. The Administrator
must administer the Plan in accordance with its terms. The
Administrator does not have the authority to alter or ignore
any of the provisions of the Plan. Similarly, a referee [arbitrator]
when called upon to review a decision of the Administrator,
must apply the relevant provisions of the Plan to the individual
circumstances of the Claimant and may not alter or ignore
any of its terms.
VII. Analysis
45. At the end of the day, the Claimant's representative was
left to argue that in this case the Traceback Procedure was
unsatisfactory and unreliable, there was evidence refuting
the Traceback result under Article 3.04(2) and that PCR tests
should be conducted on samples obtained as part of the Traceback
Procedure.
46. I can understand a certain amount of frustration on the
part of the Claimant and the Claimant's representative in
dealing with administrative bodies that have set rules and
standard operating procedures, some of which are not actually
available for public scrutiny. In addition, I can understand
a certain level of frustration and doubt when the results
of Tracebacks and blood tests of donors are provided but without
source documents. However, the Plan and Protocols as currently
written do not require the production of source documents.
47. In this case I am satisfied that the Administrator followed
properly the court approved investigation procedures including
the court-ordered Traceback Protocol.
48. I am also satisfied, based on all the evidence, that the
Heptatis C antibody test results are valid and reliable.
49. The Traceback Protocol directs the Administrator, as provided
in subsection 3.04(1) of the Plan, to reject a claim where
the Traceback information shows that all of the donors of
the blood received by a person claiming to be a Primarily-Infected
Person during the Class Period are determined not to be a
HCV antibody positive. The Administrator so rejected the claim
in this case. The rejection was subject to the Claimant's
right to provide evidence to refute the Traceback Procedure
results as provided in Section 3.04(2) of the Plan.
50. I agree with the comments of Arbitrator Wacyk, who decided
Ontario Claim No. 1402149 on February16, 2002:
[Article] 3.04(2) requires evidence that is specific
to a particular claimant, and that proves, on a balance of
probabilities, that that claimant was infected for the first
time with HCV by a Blood Transfusion received in Canada during
the Class Period.
51. In this case there was no probative evidence that the
negative HCV antibody test results, obtained as a result of
the Records Search of the first donor and the Class Period
Search relating to the second donor, were invalid or unreliable.
The absence of PCR tests is irrelevant given the wording of
the Plan and the Traceback Protocol.
52. Additionally, the scientific evidence does not support
the Claimant's assertion that she must have been infected
for the first time by the blood transfusions in 1988. As Dr.
Kleinman wrote in his report dated January 14, 2002:
Blood donors are presumably not immunocompromised, given that
they have successfully completed the blood donor interview
and have tested HIV negative. These hepatitis C testing findings
in blood donors indicate that, while it is possible for an
individual with a presumably normal immune system to test
hepatitis C PCR positive, hepatitis C antibody negative beyond
the expected 2 to 3 month interval, it is an exceedingly rare
finding (estimated to occur at a rate of 1 in 7.7 million
tested donations from the published American Red Cross data).
53. There is also the evidence from Dr. Kleinman, accepted
by Dr. Norrie, that in 10% of cases of Hepatitis C the source
of infection cannot be identified.
54. Further, both experts testified that the date of liver
failure indicates the Claimant's infection typically would
have occurred much earlier than 1988, although neither could
completely rule out the possibility of a later infection.
55. In my view, having considered all of the evidence, the
Claimant falls far short of showing on a balance of probabilities
that she was infected for the first time with HCV by a Blood
transfusion in Canada during the Class Period. On the facts
of this case, I must find that the Administrator correctly
determined that the Claimant is not entitled to compensation
pursuant to the Settlement Agreement.
56. I uphold the Administrator's denial of the Claimant's
request for compensation.
Dated at Vancouver, the 15th day of August, 2002.
____________________________
Vincent R.K. Orchard,
Arbitrator
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